The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation

Premature Birth Clinical Trial

— Neu-Prem  

Official title:

The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02605733
• Other study ID #: Neu-Prem
• Status: Completed
• Start date: October 2015
• Est. completion date: May 13, 2021

Study information

• Verified date: December 2021
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.

Description:

The investigators will measure components of brain function using two sophisticated, non-invasive technologies. First, amplitude integrated electroencephalography (EEG), a "simplified" EEG with four sensors (single channel), enables continuous non-invasive monitoring of cerebral activity. Second, near-infrared spectroscopy (NIRS) is another non-invasive technology that allows continuous real-time measurement of regional tissue oxygen utilization of the brain. Both technologies have been used in newborns and have been predictive of brain injury or neurodevelopmental impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 13, 2021
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

• 23 to 31+6 weeks gestational age at birth

Exclusion Criteria:

• Known congenital anomalies

• Parents refuse consent

• Neonatologist declined due to subject instability

Related Conditions & MeSH terms

• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia
• Neurologic Manifestations
• Premature Birth

Intervention

Device:
• EEG
amplitude integrated electroencephalography
• NIRS
regional tissue oximetry

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	The Gerber Foundation

Country where clinical trial is conducted

United States, 

References & Publications (14)

Ancora G, Maranella E, Grandi S, Sbravati F, Coccolini E, Savini S, Faldella G. Early predictors of short term neurodevelopmental outcome in asphyxiated cooled infants. A combined brain amplitude integrated electroencephalography and near infrared spectroscopy study. Brain Dev. 2013 Jan;35(1):26-31. doi: 10.1016/j.braindev.2011.09.008. Epub 2011 Nov 13. — View Citation

Ancora G, Maranella E, Locatelli C, Pierantoni L, Faldella G. Changes in cerebral hemodynamics and amplitude integrated EEG in an asphyxiated newborn during and after cool cap treatment. Brain Dev. 2009 Jun;31(6):442-4. doi: 10.1016/j.braindev.2008.06.003. Epub 2008 Jul 22. — View Citation

Benders MJ, Palmu K, Menache C, Borradori-Tolsa C, Lazeyras F, Sizonenko S, Dubois J, Vanhatalo S, Hüppi PS. Early Brain Activity Relates to Subsequent Brain Growth in Premature Infants. Cereb Cortex. 2015 Sep;25(9):3014-24. doi: 10.1093/cercor/bhu097. Epub 2014 May 27. — View Citation

Fuchs H, Lindner W, Buschko A, Almazam M, Hummler HD, Schmid MB. Brain oxygenation monitoring during neonatal resuscitation of very low birth weight infants. J Perinatol. 2012 May;32(5):356-62. doi: 10.1038/jp.2011.110. Epub 2011 Aug 18. — View Citation

Gucuyener K, Beken S, Ergenekon E, Soysal S, Hirfanoglu I, Turan O, Unal S, Altuntas N, Kazanci E, Kulali F, Koc E, Turkyilmaz C, Onal E, Atalay Y. Use of amplitude-integrated electroencephalography (aEEG) and near infrared spectroscopy findings in neonates with asphyxia during selective head cooling. Brain Dev. 2012 Apr;34(4):280-6. doi: 10.1016/j.braindev.2011.06.005. Epub 2011 Jul 7. — View Citation

Katheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014. — View Citation

Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20. — View Citation

Noori S, McCoy M, Anderson MP, Ramji F, Seri I. Changes in cardiac function and cerebral blood flow in relation to peri/intraventricular hemorrhage in extremely preterm infants. J Pediatr. 2014 Feb;164(2):264-70.e1-3. doi: 10.1016/j.jpeds.2013.09.045. Epub 2013 Oct 30. — View Citation

Peng S, Boudes E, Tan X, Saint-Martin C, Shevell M, Wintermark P. Does near-infrared spectroscopy identify asphyxiated newborns at risk of developing brain injury during hypothermia treatment? Am J Perinatol. 2015 May;32(6):555-64. doi: 10.1055/s-0034-1396692. Epub 2015 Jan 16. — View Citation

Pichler G, Avian A, Binder C, Zotter H, Schmölzer GM, Morris N, Müller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8. — View Citation

Song J, Zhu C, Xu F, Guo J, Zhang Y. Predictive value of early amplitude-integrated electroencephalography for later diagnosed cerebral white matter damage in preterm infants. Neuropediatrics. 2014 Oct;45(5):314-20. doi: 10.1055/s-0034-1382823. Epub 2014 Jul 8. — View Citation

Tao JD, Mathur AM. Using amplitude-integrated EEG in neonatal intensive care. J Perinatol. 2010 Oct;30 Suppl:S73-81. doi: 10.1038/jp.2010.93. Review. — View Citation

Toet MC, Lemmers PM. Brain monitoring in neonates. Early Hum Dev. 2009 Feb;85(2):77-84. doi: 10.1016/j.earlhumdev.2008.11.007. Epub 2009 Jan 17. Review. — View Citation

Zhang Y, Chan GS, Tracy MB, Lee QY, Hinder M, Savkin AV, Lovell NH. Cerebral near-infrared spectroscopy analysis in preterm infants with intraventricular hemorrhage. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:1937-40. doi: 10.1109/IEMBS.2011.6090547. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG	amplitude integrated EEG to measure brain activity	Birth to 72 hours of life
Primary	NIRS	Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion	Birth to 72 hours of life
Secondary	Apgar scores	1 and 5 minute Apgar scores	1, 5 and 10 minutes of life if applicable
Secondary	Cord gases	Arterial or venous pH (acid/base), base deficit	Upon delivery
Secondary	Resuscitation intervention	Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations.	From birth to 10 minutes of life
Secondary	Maximum FiO2	Maximum FiO2 during resuscitation at birth	From birth to 10 minutes of life
Secondary	Maximum peak inspiratory pressure	Peak inspiratory pressure of respiratory support	From birth to 10 minutes of life
Secondary	Heart rate		Birth to 72 hours of life
Secondary	Heart rate by EKG during resuscitation (substudy)	A substudy of 40 infants will have EKG leads placed on newborns during resuscitation; 20 will have the display blinded, and 20 will have values available to the team. The amount of resuscitation (mean airway pressure FiO2 will be compared between groups).	Birth
Secondary	Cardiac output		From neonatal intensive care unit (NICU) admission through 72 hours of life
Secondary	Mean arterial blood pressure		From NICU admission through 72 hours of life
Secondary	Use of cardiac inotropes	Dopamine, dobutamine, epinephrine	From birth through discharge to home, up to 9 months of age
Secondary	Head Ultrasound	Cranial ultrasonography	Within 24 hours of life and at approximately 72 hours of life
Secondary	MRI	Presence of brain injury (e.g. intraventricular hemorrhage (IVH), (PVL)	From birth through discharge to home, up to 9 months of age
Secondary	Neurodevelopmental impairment at 2 year follow up	Neurodevelopmental assessment at 2 year corrected gestational age	18 to 30 months corrected gestational age